As reported, approximately 2 years post op initial left tsa, this 72 y/o male patient was revised.The patient originally had an exactech reverse shoulder implanted.At some point the glenosphere became disassociated from the baseplate.Another surgeon in (b)(6) il revised the shoulder implanting the above listed implants on (b)(6) 2021 at (b)(6) (captured in 1038671-2023-01183).The baseplate and stem were not removed but screws were added and a new glenosphere and liner were implanted.After that case the glenoid baseplate became pulled out from the glenoid and was free floating in the shoulder based on xray.Surgeon scheduled a case to revise the shoulder to a hemi on (b)(6) 2023.During the case the surgeon exposed the humerus and removed both the liner and the +0 tray he then moved on to the glenoid where he was able to pull out the glenosphere including the baseplate and all screws.One screw had been broken off in the glenoid from a previous surgery or from when the glenoid component became loose.The broken screw was not retrieved and was left in the glenoid.Surgeon then implanted a 1.5 replicator plate (300-21-00 a197490) and 47 x 18 head (310-01-47 a373263).Surgeon did take 5 cultures to rule out infection, he closed and the checked stability and range of motion with both being good.Patient was last known to be in stable condition following the event.Product no being returned, reason: "patient requested explanted implants".
|
Section h10: (h3) pending evaluation: (d10) concomitant device(s): 4.5 x 30 screw, 320-20-30, s205705, 4.5 x 30 screw, 320-20-30, s205723, 38 glenosphere, 320-06-38, 6917759, locking screw, 320-15-05, 6945519, torque screw, 320-20-00, 6943087, 38 +2.5 liner, 320-38-03, s254497.
|